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A randomized, multinational, noninferiority, phase III trial to evaluate the safety and efficacy of BF‐200 aminolaevulinic acid gel vs. methyl aminolaevulinate cream in the treatment of nonaggressive…

Overview of attention for article published in British Journal of Dermatology, May 2018
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Title
A randomized, multinational, noninferiority, phase III trial to evaluate the safety and efficacy of BF‐200 aminolaevulinic acid gel vs. methyl aminolaevulinate cream in the treatment of nonaggressive basal cell carcinoma with photodynamic therapy
Published in
British Journal of Dermatology, May 2018
DOI 10.1111/bjd.16441
Pubmed ID
Authors

C.A. Morton, R. Dominicus, P. Radny, T. Dirschka, A. Hauschild, U. Reinhold, R. Aschoff, M. Ulrich, S. Keohane, S. Ekanayake‐Bohlig, S. Ibbotson, R. Ostendorf, C. Berking, D. Gröne, H.J. Schulze, H.M. Ockenfels, V. Jasnoch, H. Kurzen, M. Sebastian, H. Stege, P. Staubach, G. Gupta, F. Hübinger, I. Ziabreva, B. Schmitz, A. Gertzmann, H. Lübbert, R.‐M. Szeimies

Abstract

Basal cell carcinoma (BCC) represents the most common non-melanoma skin cancer worldwide affecting mainly adult, fair-skinned individuals. The WHO distinguishes aggressive and non-aggressive forms of which prototypical variants of the latter are primary nodular and superficial BCC. To demonstrate non-inferiority of BF-200 ALA (a nanoemulsion gel containing 5-aminolaevulinic acid) compared to MAL (a cream containing methyl-aminolevulinate) in the treatment of non-aggressive BCC with photodynamic therapy (PDT). Non-inferiority of the primary efficacy variable (overall patient complete response 12 weeks after last PDT) would be declared if the mean response for BF-200 ALA was no worse than that for MAL, within a statistical margin of Δ = -15%. The study was a randomized, phase III trial performed in Germany and the UK with ongoing 5-year follow-up. Of 281 randomized patients, 138 were treated with BF-200 ALA, 143 with MAL. Patients received two PDT sessions one week apart. Remaining lesions 12 weeks after the second PDT were retreated. Illumination was performed with a red light source (635 nm, 37 J/cm2 ). Results shown include clinical endpoints as well as patients' reassessment 12 months after the last PDT. Of the BF-200 ALA-treated patients, 93.4% were complete responders compared to 91.8% in the MAL group. The difference of means was 1.6 with a one-sided 97.5% CI of -6.5, establishing non-inferiority (p<0.0001). Results for secondary efficacy parameters were in line with the primary outcome. Recurrence rates 12 months after the last treatment were ≤ 10%. Treatment of non-aggressive BCC with BF-200 ALA-PDT is highly effective and well tolerated with proven non-inferiority to MAL-PDT and demonstrates low recurrence rates after 1-year follow-up. This article is protected by copyright. All rights reserved.

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X Demographics

The data shown below were collected from the profiles of 4 X users who shared this research output. Click here to find out more about how the information was compiled.
Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 54 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 54 100%

Demographic breakdown

Readers by professional status Count As %
Student > Bachelor 7 13%
Researcher 6 11%
Student > Master 4 7%
Student > Ph. D. Student 3 6%
Other 2 4%
Other 8 15%
Unknown 24 44%
Readers by discipline Count As %
Medicine and Dentistry 11 20%
Pharmacology, Toxicology and Pharmaceutical Science 4 7%
Biochemistry, Genetics and Molecular Biology 2 4%
Chemistry 2 4%
Psychology 1 2%
Other 5 9%
Unknown 29 54%
Attention Score in Context

Attention Score in Context

This research output has an Altmetric Attention Score of 3. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 02 October 2018.
All research outputs
#15,097,241
of 25,382,440 outputs
Outputs from British Journal of Dermatology
#6,072
of 9,663 outputs
Outputs of similar age
#180,046
of 342,098 outputs
Outputs of similar age from British Journal of Dermatology
#108
of 258 outputs
Altmetric has tracked 25,382,440 research outputs across all sources so far. This one is in the 40th percentile – i.e., 40% of other outputs scored the same or lower than it.
So far Altmetric has tracked 9,663 research outputs from this source. They typically receive more attention than average, with a mean Attention Score of 9.6. This one is in the 36th percentile – i.e., 36% of its peers scored the same or lower than it.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 342,098 tracked outputs that were published within six weeks on either side of this one in any source. This one is in the 46th percentile – i.e., 46% of its contemporaries scored the same or lower than it.
We're also able to compare this research output to 258 others from the same source and published within six weeks on either side of this one. This one has gotten more attention than average, scoring higher than 56% of its contemporaries.